Public Consultation on the Draft of the Safety of Toys (Amendment)Regulations, 2012

The European Food Safety Authority (EFSA) concluded in its opinion of 30 January 2009 that the tolerable weekly intake of cadmium was no longer appropriate in view of the new developments related to the toxicology of cadmium. The EFSA established a new tolerable weekly intake of 2.5 μg/kg, resulting in a tolerable daily intake of 0.36 μg/kg. The tolerable amount of Cadmium present in toys was therefore amended by means of Directive 2012/7/EU so as to be within the limits considered to be safe and therefore ensure the safety of children when using products covered by the Toy Safety Directive (2009/48/EC).

The deadline for comments on the proposed draft is 9 July 2012.

Proposal

The entry for Cadmium in the table listing migration limits from toys or components of toys in point (15) of Part IV of Schedule I to the Safety of Toys Regulations, 2011 shall be replaced by the following values: 17 mg/kg for scrapped- off material, 1.3 mg/kg for dry material and 0.3 mg/kg for liquid material.

Background

Directive 2009/48/EC sets limit values for cadmium, based on the recommendations of the Dutch National Institute for Public Health and the Environment (RIVM) made in the 2008 report entitled "Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on elements".

For cadmium, RIVM used the tolerable weekly intake of 7 μg/kg established by the Joint Food and Agriculture Organisation of the United Nations and the World Health Organisation Experts committee on food additives (JEFCA) in 1989 and confirmed by JECFA in 2001. A safety factor of two was applied, resulting in a tolerable weekly intake of 3.5 μg/kg and a tolerable daily intake of 0.5 μg/kg. The European Food Safety Authority (EFSA) concluded in its opinion of 30 January 2009 that the tolerable weekly intake established by JEFCA in 1989 and confirmed by JECFA in 2001 was no longer appropriate in view of the new developments related to the toxicology of cadmium.

The EFSA established a new tolerable weekly intake of 2.5 μg/kg, resulting in a tolerable daily intake of 0.36 μg/kg. The tolerable amount of Cadmium present in toys needs therefore to be amended so as to be within the limits considered to be safe and therefore ensure the safety of children when using products covered by the Toy Safety Directive (2009/48/EC). Who would be interested Manufacturers, importers and distributors (sellers) of toys. What will be affected Toys falling within the scope of the Toy Safety Directive (2009/48/EC). Dates Feedback to be received by the 9th July 2012.

Contacts Comments to be sent to the Regulatory Affairs Directorate, Technical Regulations Division, Malta Competition and Consumer Affairs Authority by e-mail –